Clinical trial · Interventional
Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer
NCT01268943CI-TRIAL-00017393completedPhase 1Results postedClinicalTrials.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 purpose of this study is to seek the proper dose of capecitabine in post-operative concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical surgery, and evaluate the toleration of this modality in such patients.
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 |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1000mg
- description
- capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- 1200mg
- description
- capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- 1400mg
- description
- capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 71 Years
Show eligibility criteria text
Inclusion Criteria: * rectal adenocarcinoma, pathological stage II/III(T3-4 or N+, UICC 2002), radical surgery received. * interval between surgery and enrollment no less than two week and no more than 3 months. * KPS status no less than 70; life expectancy no less than 6 months. * without life-threatening complications, such as severe hypertension, coronary heart disease, cerebral vascular disease, uncontrolled diabetes, etc. * without severe drug allergy history. * hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L. * Creatin \<= 1.5\* ULN(upper limit of normal), Total bilirubin \<= 2.5 ULN, AST and AST \<= 2.5\* ULN, AKP \<= 2.5\*ULN * do not receive chemotherapy before six months from enrollment. * no previously pelvic irradiation history * informed consent signed Exclusion Criteria: * other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma * allergy history to thymidine phosphorylase * previous pelvic irradiation history * receiving adjuvant chemotherapy in six months before enrollment * active infection existed * severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L), severe cardiac arrhythmia, etc. * life expectancy less than 6 months * estimated cannot finish treatment * attend other clinical trials in four weeks before enrollment * receive other anti-cancer treatment currently * other conditions which regarded illegal by censors with full reasons. for example, some conditions may conflict from the protocol.
References
Publications (26)
- BACKGROUNDColorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8,507 patients from 22 randomised trials. Lancet. 2001 Oct 20;358(9290):1291-304. doi: 10.1016/S0140-6736(01)06409-1. PMID 11684209
- BACKGROUNDTveit KM, Guldvog I, Hagen S, Trondsen E, Harbitz T, Nygaard K, Nilsen JB, Wist E, Hannisdal E. Randomized controlled trial of postoperative radiotherapy and short-term time-scheduled 5-fluorouracil against surgery alone in the treatment of Dukes B and C rectal cancer. Norwegian Adjuvant Rectal Cancer Project Group. Br J Surg. 1997 Aug;84(8):1130-5. PMID 9278661
- BACKGROUNDFisher B, Wolmark N, Rockette H, Redmond C, Deutsch M, Wickerham DL, Fisher ER, Caplan R, Jones J, Lerner H, et al. Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer: results from NSABP protocol R-01. J Natl Cancer Inst. 1988 Mar 2;80(1):21-9. doi: 10.1093/jnci/80.1.21. PMID 3276900
- BACKGROUNDKrook JE, Moertel CG, Gunderson LL, Wieand HS, Collins RT, Beart RW, Kubista TP, Poon MA, Meyers WC, Mailliard JA, et al. Effective surgical adjuvant therapy for high-risk rectal carcinoma. N Engl J Med. 1991 Mar 14;324(11):709-15. doi: 10.1056/NEJM199103143241101. PMID 1997835
- BACKGROUNDWolmark N, Wieand HS, Hyams DM, Colangelo L, Dimitrov NV, Romond EH, Wexler M, Prager D, Cruz AB Jr, Gordon PH, Petrelli NJ, Deutsch M, Mamounas E, Wickerham DL, Fisher ER, Rockette H, Fisher B. Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02. J Natl Cancer Inst. 2000 Mar 1;92(5):388-96. doi: 10.1093/jnci/92.5.388. PMID 10699069
- BACKGROUNDGastrointestinal Tumor Study Group. Prolongation of the disease-free interval in surgically treated rectal carcinoma. N Engl J Med. 1985 Jun 6;312(23):1465-72. doi: 10.1056/NEJM198506063122301. PMID 2859523