Trial · NCT01515787
PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
NCT01515787, Phase 2, Phase 3, Unknown, Alliance for Clinical Trials in Oncology; results first posted 2024-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery. Trials, record NCT01515787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01515787
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
- NCT number
- NCT01515787
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,194 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Colorectal Cancer
- Interventions
- FOLFOX (chemotherapy), 5 FUCMT (chemoradiation), surgery, magnetic resonance imaging or endorectal ultrasound
- First posted
- 2012-01-24
- Last updated
- 2024-02-02
- Results first posted
- 2024-02-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pelvic R0 Resection Rate | Up to 5 years | Number of Participants with Pelvic R0 Resection |
| Primary | DFS | Up to 5 years | Disease-free Survival (DFS): The distribution of DFS by group will be estimated using the method of Kaplan-Meier. 5 year disease free rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. Log-rank test will be used to compare DFS between two treatment groups. Hazard ratio with confidence interval will be estimated based on Cox proportional hazard model. The Cox proportional hazard model will be used for multivariate analysis. |
| Secondary | Pathologic Complete Response | Up to 8 years | Pathologic Complete Response (pCR): The pCR rate is defined as number of patients who achieve pCR divided by total number of patients included in the analysis population (see definition in Section 16.3.3.1) in each group. Patients who didn't undergo surgery will be classified as non-pCR. Point estimate and confidence interval (according to approach of Duffy and Santner) will be calculated by treatment groups. Chi-square test will be used to compare the pCR rates between groups. |
| Secondary | Overall Survival | Up to 5 years | Overall Survival (OS): OS is defined as time from randomization to the date of death due to all causes. The distribution of OS by group will be estimated using the method of Kaplan-Meier. Five year survival rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. Logrank test will be used to compare OS between two treatment groups. Hazard ratio with confidence interval will be estimated based on Cox proportional hazard model. The Cox proportional hazard model will be used for multivariate analysis. |
| Secondary | Rates of Receiving Pre- or Post-operative 5FUCMT | Up to 5 years | Rates of Receiving 5FUCMT: For selective group patients, the proportion of patients who received 1) pre-operative 5FUCMT, 2) post-operative 5FUCMT, 3) either pre or post-operative 5FUCMT, and confidence intervals (according to approach of Duffy and Santner) will be reported. |
| Secondary | Local Recurrence (TLR): | Up to 5 years | Time to Local Recurrence (TLR): The distribution of TLR by group will be estimated using the method of Kaplan-Meier. 5 year local recurrence free rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. The comparison of the cumulative incidence of local recurrence between groups, treating distant recurrence and death as competing risks using the test of Gray (Annals of Statistics, 1988) will be conducted. |
| Secondary | Neoadjuvant Rectal Score | Up to 5 years | neoadjuvant rectal (NAR) score =\[5 \* pN - 3(cT - pT) + 12\]\^2/9.61. cT is an element of the set {1, 2, 3, 4}, pT is in {0, 1, 2, 3, 4}, and pN is in {0, 1, 2}. cT clinical tumor stage, pT pathologic tumor stage, pN pathologic nodal stage. Low (NAR \<8), intermediate (NAR = 8-16), and high (NAR \>16). Low is better and high is worse. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pelvic R0 Resection Rate | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | DFS | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pathologic Complete Response | Up to 8 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rates of Receiving Pre- or Post-operative 5FUCMT | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Local Recurrence (TLR): | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Neoadjuvant Rectal Score | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pelvic R0 Resection Rate | Group 1 | 529 | Participants | ||
| Pelvic R0 Resection Rate | Group 2 | 495 | Participants | ||
| DFS | Group 1 | 114 | Participants | ||
| DFS | Group 2 | 113 | Participants | ||
| Pathologic Complete Response | Group 1 | 117 | Participants | ||
| Pathologic Complete Response | Group 2 | 124 | Participants | ||
| Overall Survival | Group 1 | 74 | Participants | ||
| Overall Survival | Group 2 | 67 | Participants | ||
| Rates of Receiving Pre- or Post-operative 5FUCMT | Group 1 | 61 | Participants | ||
| Rates of Receiving Pre- or Post-operative 5FUCMT | Group 2 | 543 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 597 | |
| Overall Study | STARTED | Group 2 | 597 | |
| Overall Study | COMPLETED | Group 1 | 585 | |
| Overall Study | COMPLETED | Group 2 | 543 | |
| Overall Study | NOT COMPLETED | Group 1 | 12 | |
| Overall Study | NOT COMPLETED | Group 2 | 54 |
Source ClinicalTrials.gov
Adverse events712
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Group 1 | 74 | 585 | 168 |
| other | Anemia | Blood and lymphatic system disorders | Group 2 | 65 | 543 | 106 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Group 1 | 5 | 585 | 9 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Group 2 | 3 | 543 | 4 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Group 1 | 0 | 585 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Group 2 | 1 | 543 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group 1 | 12 | 585 | 13 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group 2 | 1 | 543 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Group 1 | 1 | 585 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Group 2 | 1 | 543 | 2 |
1 to 10 of 712Source ClinicalTrials.gov
See all 712 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | 74 | 585 |
| Total, all-cause mortality | Group 2 | 67 | 543 |
| Total, other adverse events | Group 1 | 582 | 585 |
| Total, other adverse events | Group 2 | 534 | 543 |
| Total, serious adverse events | Group 1 | 10 | 585 |
| Total, serious adverse events | Group 2 | 7 | 543 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1 vs Group 2: Overall Survival | Trial comparisons |
| Group 1 vs Group 2: DFS | Trial comparisons |
| Group 1 vs Group 2: Pelvic R0 Resection Rate | Trial comparisons |
| Group 1 vs Group 2: Local Recurrence (TLR): | Trial comparisons |
| Group 1 vs Group 2: Pathologic Complete Response | Trial comparisons |
| Group 1 vs Group 2: Rates of Receiving Pre- or Post-operative 5FUCMT | Trial comparisons |
| Group 1 vs Group 2: deaths from any cause | Trial comparisons |
| Group 1 vs Group 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01515787
GET https://conductscience.org/api/trials/v1/NCT01515787/events?page=2