Comparison · NCT02017704-sae
IMRT and Capecitabine vs Endo-HDR: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. IMRT and Capecitabine vs Endo-HDR: serious adverse events. Trial comparisons, record NCT02017704-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02017704-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.25 | 0.0456 | 0.699 | wilson | |
| Risk in group 2 | 0.4 | 0.118 | 0.769 | wilson | |
| Risk difference, group 1 minus group 2 | -0.15 | -0.572 | 0.381 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.625 | 0.0839 | 4.66 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.0279 | 8.95 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on IMRT and Capecitabine than on Endo-HDR | 6.67 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | IMRT and Capecitabine | Patients will receive IMRT along with capecitabine.~Followed by:~* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion~* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions~* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles~Then: Surgical Resection capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy~IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.~External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications~FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion~* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions~* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus~Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. | 1 | 4 | EG000 |
| Group 2 | Endo-HDR | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy~Followed by:~* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion~* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions~* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles~Then: Surgical Resection:~Endo-HDR: Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy~FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion~* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions~* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus;~Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. | 2 | 5 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 60 months
Source ClinicalTrials.gov
Trial
- Title
- Chemoradiation or Brachytherapy for Rectal Cancer
- NCT number
- NCT02017704
- Phases
- PHASE2
- Conditions
- Rectal Cancer
- Interventions
- Endo-HDR (if randomized to this arm), capecitabine and IMRT (if randomized to this arm), IMRT (intensity modulated radiation therapy), FOLFOX6, Surgery
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Results first posted
- 2023-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02017704?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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