Clinical trial · Interventional

Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients

Randomised Phase III Trial of Chemoradiotherapy With or Without Paclitaxel in Patients With Squamous-cell Anal Cancer

NCT02526953CI-TRIAL-00049965unknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Anus Diseases	—	UNRESOLVED	—
Anus Neoplasms	Anal Neoplasm	ALIAS	0.90
Carcinoma	Carcinoma	ONTOLOGY_EXACT	0.98
Carcinoma, Squamous Cell	Squamous Cell Carcinoma	ONTOLOGY_EXACT	0.98
Neoplasms	Neoplasm	ONTOLOGY_EXACT	0.90
Neoplasms, Squamous Cell	Squamous Cell Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Capecitabine	Drug	Capecitabine	ALIAS
Mitomycins	Drug	—	UNRESOLVED
Paclitaxel	Drug	Paclitaxel	ALIAS
Radiotherapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Paclitaxel
description
Patients will receive intensity-modulated radiotherapy with dose based on T stage. The planned doses to the primary tumor and pelvis are 52-58 Gy and 44 Gy, respectively.The concurrent chemotherapy regimen will consist of paclitaxel 45 mg/m2 on days 3,10,17,24,31, capecitabine 625 mg/m2 bid on treatment days and mitomycin C 10 g/m2 on day 1.
interventionNames
1. Drug: Paclitaxel
2. Drug: Capecitabine
3. Drug: Mitomycins
4. Radiation: Radiotherapy
type
ACTIVE_COMPARATOR
label
Standard
description
Patients will receive intensity-modulated radiotherapy with dose based on T stage. The planned doses to the primary tumor and pelvis are 52-58 Gy and 44 Gy, respectively.The concurrent chemotherapy regimen will consist of capecitabine 825 mg/m2 bid on treatment days and mitomycin C 12 g/m2 on day 1.
interventionNames
1. Drug: Capecitabine

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* Informed consent
* Histologically verified squamous-cell anal cancer
* Stage I-IIIB (Union for International Cancer Control (UICC) TNM classification v7)
* Eastern Cooperative Oncology Group (ECOG) status 0-2
* HIV (Human Immunodeficiency Virus) negative
* Haemoglobin (HGB) \> 90 g/L
* Platelet Count (PLT) \> 120x10\*9/L
* Serum creatinine \< 150 µmol/L
* Total bilirubin \< 25 µmol/L

Exclusion Criteria:

* inability to obtain informed consent
* distant metastases
* synchronous or metachronous tumors
* previous chemotherapy or radiotherapy
* clinically significant cardiovascular disorders (myocardial infarction \< 6 months before visit, stroke \< \< 6 months before visit, instable angina \< 3 months before visit, arrhythmia, uncontrolled hypertension \> 160/100 mm hg
* clinically significant neurological disorders
* previous neuropathy 2 or higher
* current infection or heavy systemic disease
* pregnancy, breastfeeding
* ulcerative colitis
* individual intolerance to treatment components
* proven dihydropyrimidine dehydrogenase (DPD) deficiency
* participation in other clinical trials
* psychiatric disorders, which render patient unable to follow instructions or understand his/her condition
* technical inability to perform pelvic MRI
* inability of long-term followup of the patient

References

Publications (0)

Data not yet available

No reference posted for this study.