Clinical trial · Interventional
A Phase II Study to Assess Acute Toxicity and Quality of Life of Patients With Carcinoma of the Anal Canal Receiving Chemotherapy and Radiation Using Helical Tomotherapy
NCT00754078CI-TRIAL-00022892unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Canal Cancer | Anal Canal Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tomotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- anal cancer patients treated with tomotherapy and chemotherapy
- interventionNames
- Radiation: Tomotherapy
Primary outcomes (1)
- measure
- Acute Toxicity and Quality of LIfe
- timeFrame
- 3 months
Secondary outcomes (2)
- measure
- colostomy-free survival and/or overall survival
- timeFrame
- 3 and 5 years
- measure
- Local Recurrence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient should have histologically proven primary squamous carcinoma or its variant * No history of prior malignancy. * Patients must be free of metastatic disease out of pelvis at the time of diagnosis * Patients must be at least 18 years of age * Performance status 0, 1 or 2 ECOG * T stage 2-4, Any N, stage MO * Patient should be eligible for concomitant chemotherapy * Informed written consent required to participate Exclusion Criteria: * Prior radiation to pelvis * Pregnant or lactating * prior surgical treatment for anal cancer other than biopsy * prior surgical or chemotherapy treatment for anal cancer * T1 tumours (2cm) or evidence of distant mets * comorbid medical conditions precluding radical treatment at the discretion of oncologist
References
Publications (0)
Data not yet available
No reference posted for this study.